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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K241866
Device Name InnovaMatrix®FD
Applicant
Convatec Triad Life Sciences, LLC
1770 Moriah Woods Blvd.
Memphis,  TN  38117
Applicant Contact Victoria Beifuss
Correspondent
Convatec Triad Life Sciences, LLC
1770 Moriah Woods Blvd.
Memphis,  TN  38117
Correspondent Contact Victoria Beifuss
Classification Product Code
KGN  
Date Received06/27/2024
Decision Date 07/26/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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